Clearance Summary
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY received FDA 510(k) clearance under submission number K130235, sponsored by Hans Biomed Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-01-10.
- Submission: K130235
- Applicant / Sponsor: Hans Biomed Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2014-01-10
Classification & Regulation
This clearance is catalogued under FDA product code NUN and 21 CFR 872.3930, within the Dental review panel as a Class II device.